| CTRI Number |
CTRI/2019/02/017549 [Registered on: 08/02/2019] Trial Registered Prospectively |
| Last Modified On: |
03/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Utility of CB-NAAT (a diagnostic test) in diagnosing cases of skin tuberculosis. |
|
Scientific Title of Study
|
CB-NAAT, Its clinical utility in diagnosing cases of cutaneous tuberculosis and assessing rifampicin resistance. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PARUL VERMA |
| Designation |
Assistant Professor |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
502 B , HALWASIYA LOREPUR RESIDENCY , NEW HYDERABAD
Department of Dermatology Venereology and Leprosy, KGMU, Lucknow, UP
Lucknow
UTTAR PRADESH
226007
India |
| Phone |
7703056441 |
| Fax |
|
| Email |
parulverma6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PARUL VERMA |
| Designation |
Assistant Professor |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
502 B , HALWASIYA LOREPUR RESIDENCY , NEW HYDERABAD
Department of Dermatology Venereology and Leprosy, KGMU, Lucknow, UP
Lucknow
UTTAR PRADESH
226007
India |
| Phone |
7703056441 |
| Fax |
|
| Email |
parulverma6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PARUL VERMA |
| Designation |
Assistant Professor |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
502 B , HALWASIYA LOREPUR RESIDENCY , NEW HYDERABAD
Department of Dermatology Venereology and Leprosy, KGMU, Lucknow, UP
Lucknow
UTTAR PRADESH
226007
India |
| Phone |
7703056441 |
| Fax |
|
| Email |
parulverma6@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) |
| King Georges Medical University, Lucknow, UP |
|
|
Primary Sponsor
|
| Name |
King Georges Medical University |
| Address |
King Georges Medical University, LUCKNOW, UP |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parul Verma |
King Georges Medical University, Lucknow, up |
Department of Dermatology Venereology and Leprosy, KGMU, Lucknow
Lucknow
UTTAR PRADESH |
7703056441
parulverma6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University, Institutional Ethics Committee, Lucknow, UP, India 226003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
(a) Patients clinically diagnosed as cutaneous TB and who give consent to participate in
the study
|
|
| ExclusionCriteria |
| Details |
(a) Who have taken ATT in last one year
(b) Contra-indication for biopsy or FNAC like bleeding and clotting disorders
(c) Patients with severe debilitating and chronic illness like Hepatitis B,C, malignancy,
uncontrolled diabetes etc
(d) Not willing to participate in study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the efficacy of CBNAAT, culture and histopathological
examination (including staining for AFB) in diagnosing cases of cutaneous TB. |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment and comparison of Rifampicin resistance results shown
by CBNAAT and DST (for cases that show culture growth). |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a prospective study to compare the diagnostic efficacy of CB-NAAT, culture and histopathology in cases of skin tuberculosis. It also aims at knowing the efficacy of CB-NAAT in detecting rifampicin resistance and comparing it with DST (Culture) results in positive culture cases. |